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Job #02836

About our client Our client is a leading medical device company specialized in ophthalmology and eye care products. They have over 13,000 employees globally and a reputation as a leading innovator in the field. With operations in 36 countries and a 150-year track record of success, this is a great situation for a candidate that is pursuing a challenging opportunity with a world-class employer. Position Location Clinical Project Leader New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage and monitor (independently) all aspects of implementation of pharmaceutical clinical studies as per FDA regulations, ICH and GCP guidelines for clinical research studies and company SOPs 2) Monitor on-site and in-house activities (as needed and required by GCP) 3) Manage the project for clinical sites and field CRAs assigned to projects (as needed and required by GCP) 4) Contribute to clinical research study design, QA, data management and reporting activities 5) Identify and evaluate issues related to the project and implement resolutions 6) Provide input on departmental decisions related to process and procedures 7) Plan and create presentations of clinical research study information 8) Participate in designing and developing CRFs 9) Conduct project planning, budgeting and expense analysis 10) Participate in Investigator recruitment and provide final recommendations Requirements 1) BA/BS degree (scientific field preferred) 2) CRA certification a plus 3) 3+ years of experience as a CRA 4) 2+ years of experience in supervising CRAs (as a Lead CRA or PM) 5) Minimum 2 years of experience in managing clinical trials and clinical trial resources (or experience in a similar position, demonstrating project management expertise) 6) Minimum 4 years of experience as a medical device/pharmaceutical CRM (or equivalent), with in-house and field monitoring background in a CRO, medical device or pharmaceutical company